BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 1.5X105MM 22MM STP J-NT

    MDR report key: 22053024 · Received May 20, 2025

    Report

    Report Number
    0001032347-2025-00213
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 24, 2025
    Report Date
    October 10, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    K062842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS. ITEM# 01-9198, LOT# 66250040, DRILL 1.5X105MM 22MM STP J-NT. G2: FOREIGN SOURCE: MALAYSIA. H6: COMPONENT CODE: MECHANICAL (G04) ¿ DRILL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND/OR CORRECTED INFORMATION. UPDATED: B5, G3, H2, H3, H4, H6 AND H11. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER AND PRODUCT WAS NOT RETURNED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT IS REPORTED THAT DURING A PROCEDURE TO FIX A MANDIBLE RAMUS FRACTURE, THE SURGEON WAS DRILLING THE MANDIBLE BONE WHEN THE DRILL TIP FRACTURED. SUBSEQUENTLY, THE SURGEON USED ANOTHER TWIST DRILL, AND THE TIP ALSO FRACTURED WHILE DRILLING. THE DRILL BITS WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT INSTRUMENT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370120 DRILL 1.5X105MM 22MM STP J-NT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION 66250040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown